1st Shift Production Sterilization Specialist

Harrowhealth; Ledgewood (NJ); On-site; USD 48,000 - 70,000; Full time

Job summary

Harrow seeks a Production Sterilization Specialist to support labeling, packaging, and production activities in a regulated manufacturing setting. You will work under ISO7/ISO8 classified areas with sterile equipment and perform cleaning, disinfection, and material staging for production.

Responsibilities include maintaining logs, following SOPs, and adhering to cGMP and safety policies while operating aseptic processes in a fast-paced environment.

Qualifications

• High School Diploma or equivalent.
• 1–3 years of pharmaceutical industry experience in aseptic clean rooms.
• Ability to gown into aseptic manufacturing areas.
• Ability to handle sensitive information with confidentiality.
• Ability to work in a fast-paced environment with strong time management and organization.
• Proficient in Microsoft Office including Excel, Outlook, and Word.

Responsibilities

• Ensure work complies with cGMP, Safety Policies, and SOPs.
• Wear proper PPE and follow aseptic gowning procedures.
• Report accidents or hazards immediately to the manager.
• Maintain accurate product documentation and cleaning logs per SOPs.
• Maintain knowledge of current cGMP guidelines.
• Prioritize tasks and manage heavy workloads under pressure.
• Clean, sanitize, and disinfect production equipment and areas.
• Coordinate with Warehouse to ensure materials are ready for production.
• Stage materials for production use.
• Operate cleaning equipment (Autoclave, Fedegari, Depyrogentation oven).
• Calibrate check weighing as needed.

Skills

Gowning in aseptic areas

Time management

Organization

Confidentiality

Fast-paced work environment

Education

High School Diploma

Tools

Excel

Outlook

Word

Job description

Before reading the job post, we encourage you to watch this video about our company. It gives you an inside look at how we started, the team and culture that made us successful, and where we're going. It's easy to read a job post and apply, but people often wonder about the culture and whether they would fit in.

Who is Harrow?

Harrow (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America. Harrow is an incredible entrepreneurial company – where we celebrate the ability of every member of the Harrow Family to be the CEO of their job. Harrow’s values have driven interest over the past decade in attracting high-performing professionals in a variety of disciplines. Members of our Harrow Family often express their pride in being a part of our commitment to (1) innovation, (2) patient access to affordable medicines, and (3) our track record of having never turned down an ophthalmologist doing mission work around the world –providing free medicines in support of mission work aimed at giving or maintaining the gift of sight to those most in need

Harrow’s ophthalmic pharmaceutical portfolio is one of the most comprehensive in the industry, including:

• An expanding Retina Portfolio including IHEEZO®, TRIESENCE®, BYOOVIZTM, and OPUVIZTM
• A broad Dry Eye Disease product line, led by VEVYE® and bolstered by well-known adjacent ocular surface disease products such as FLAREX® and FRESHKOTE®
• A peri-operative Surgical product line, led by TRIESENCE®, and BYQLOVI™
• A Rare and Specialty product line, which includes various high-need and utility products such as ILEVRO®, NATACYN®, and VERKAZIA®
• A robust internal development pipeline with multiple late-stage candidates, including MELT-300, MELT-210, H-N08, and CR-01

Job Summary

TheProduction Sterilization Specialistwill be responsible for conducting labeling, packaging, and production support activities to support commercial manufacturing. Under the direction of the Production Supervisor/Team Leader, the Production Support Associate will work hands-on under ISO7, ISO8, and other classified areas with various manufacturing production equipment and technologies. Daily responsibilities vary, including operating cleaning machines and preparing supplies for manufacturing by cleaning and disinfecting.

Core Responsibilities

• Ensures that all work is carried out in compliance with company Safety Policies, current Good Manufacturing Practices (cGMP), and Standard Operating Procedures (SOPs).
• Wears proper personal protective equipment and follows aseptic procedures when gowning, de-gowning, and working in sterile and controlled areas.
• Reports any accidents, incidents, injuries, or illnesses immediately and notifies the manager of any workplace hazards, unsafe acts, or conditions.
• Accurate completion of product documentation and all appropriate logbooks. Maintains cleaning logs per SOP requirements.
• Knowledge of current Good Manufacturing Practices (cGMP) guidelines.
• Excellent organization and time-management skills are required. Must promptly manage a heavy workload and aggressive timelines, prioritize, and work under pressure.
• Cleaning, sanitizing, and disinfection of equipment and components required for production.
• Works with the Warehouse Department to ensure all components are available ahead of time for production.
• Completes all necessary cleaning and sanitizing of production equipment and area.
• Stages material for production use.
• Operation of cleaning equipment including but not limited to Autoclave, Fedegari, and Depyrogentation oven.
• Performs calibration of check weighing.

Qualifications & Requirements

• High School Diploma or equivalent work and education in a related field are required.
• 1-3 years of experience working in the pharmaceutical industry and within aseptic clean room environments.
• Demonstrated ability to successfully gown into aseptic manufacturing areas.
• Ability to handle sensitive information with a high degree of confidentiality.
• Ability to work in a fast-paced environment while demonstrating excellent time management and organization skills.
• Proficient in using standard Microsoft Office software products, including Excel, Outlook, and Word.
• Strong organizational skills with the proven ability to prioritize.
• Works with a sense of urgency while engaging and listening to experts.

Position Type

• On-Site

Travel

• None